NCT00665600

Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)

A Double-Blind, Randomized, Multicenter, Parallel-Group Study of Levalbuterol in the Treatment of Subjects With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 257 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 35 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of repeated dosing of Levalbuterol over 6 weeks of treatment in COPD.

Detailed description

This study is a multi-center, randomized, double-blind, placebo and active controlled, parallel-group study of adult subjects with COPD. Approximately 250 subjects will be enrolled to randomize at least 200 subjects. Study participation will consist of a total of six study visits over nine weeks for each subject. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Levalbuterol HCl	Levalbuterol 0.63 TID
DRUG	Levalbuterol HCl	Levabuterol 1.25 mg TID
DRUG	Albuterol Sulfate	Racemic albuterol 2.5 mg TID
DRUG	Placebo	Placebo TID

Timeline

• Start date: 2002-02-01
• Primary completion: 2003-03-01
• Completion: 2003-03-01
• First posted: 2008-04-24
• Last updated: 2023-06-27

Locations

24 sites across 2 countries: United States, Canada